« Previous
Next »
Titles
- ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs1
- COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators1
- Competitive generic therapies1
- FDA oversight1
- Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment1
- Providing regulatory submissions in electronic format: certain human pharmaceutical product applications and related submissions using the eCTD specifications1
- Risk evaluation and mitigation strategies: modifications and revisions1
- The "deemed to be a license" provision of the BPCI Act: questions and answers1